Research & Scholarship

Current Research and Scholarly Interests

Clinical Trials

Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and InfantsRecruiting

To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of
study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the
first 28 days of study treatment, confirmed by a second sample collected 7 days after the
first sample.

Projects

Collaboration with University of California, Davis School of Veterinary Medicine to measure neurosteroid levels in infants to determine whether they are affected by skin-to-skin contact, thereby influencing neurodevelopment. Skin-to-skin contact between mother and child shortly after birth has been linked with improved infant growth, breastfeeding and attachment, and, for preterm infants, enhanced neurodevelopment. The biological basis for this in humans is unclear, however in horses, high levels of neuroactive steroids in newborn foals can induce abnormal behavior including a failure to breastfeed. We will track neurosteroid levels in human infants, both full-term and premature, some of whom receive routine skin-to-skin contact, to identify any associations between the two that could identify potential neurodevelopmental defects amenable to treatment with skin-to-skin contact.

Abstract

To determine the postnatal course of neurosteroid levels in relation to gender, mode of delivery and the extent of skin-to-skin (STS) contact during the first days of life in healthy term newborns.Prospective observational study of 39 neonates in which parents recorded total duration of STS in the first 2 days and nine neurosteroids (dehydroepiandrosterone-sulfate, progesterone, pregnenolone, pregnenolone-sulfate, allopregnanolone, isopregnanolone, epipregnanolone, pregnanolone and pregnanolone-sulfate) were assayed from blood samples at birth and at 1-2 days of age.All nine neurosteroid levels declined significantly during the first 2 days of life. Gender did not significantly affect the change in neurosteroid levels. The decline in neurosteroid levels was generally more pronounced in vaginal deliveries, and there was a trend toward a larger decline with more exposure to STS.Ongoing studies may better characterize the role of neurosteroids and the influence of STS in more critically ill and premature neonates.

Abstract

The objective of this study was to evaluate the impact of a standardized enteral feeding protocol for very low birth weight (VLBW) infants on nutritional, clinical and growth outcomes.Retrospective analysis of VLBW cohorts 9 months before and after initiation of a standardized feeding protocol consisting of 6-8 days of trophic feedings, followed by an increase of 20 ml/kg/day. The primary outcome was days to reach full enteral feeds defined as 160 ml/kg/day. Secondary outcomes included rates of necrotizing enterocolitis and culture-proven sepsis, days of parenteral nutrition and growth end points.Data were analyzed on 147 VLBW infants who received enteral feedings, 83 before ('Before') and 64 subsequent to ('After') feeding protocol initiation. Extremely low birth weight (ELBW) infants in the After group attained enteral volumes of 120 ml/kg/day (43.9 days Before vs 32.8 days After, P=0.02) and 160 ml/kg/day (48.5 days Before vs 35.8 days After, P=0.02) significantly faster and received significantly fewer days of parenteral nutrition (46.2 days Before vs 31.3 days After, P=0.01). Necrotizing enterocolitis decreased in the After group among VLBW (15/83, 18% Before vs 2/64, 3% After, P=0.005) and ELBW infants (11/31, 35% Before vs 2/26, 8% After, P=0.01). Late-onset sepsis decreased significantly in the After group (26/83, 31% Before vs 6/64, 9% After, P=0.001). Excluding those with weight <3rd percentile at birth, the proportion with weight <3rd percentile at discharge decreased significantly after protocol initiation (35% Before vs 17% After, P=0.03).These data suggest that implementation of a standardized feeding protocol for VLBW infants results in earlier successful enteral feeding without increased rates of major morbidities.